Read time: 4 minutes.
We are buzzing with energy after LUNGevity Foundation’s Transforming Clinical Trials Initiative (TCTI) Regulatory Series Part 1 Roundtable on September 18. Thank you to all of our partners who attended this impactful multi-stakeholder meeting and made the lively discussion possible. In addition to our meeting, we are celebrating the publication of our recent manuscript on streamlining the schedule of assessments in clinical trials and continuing to be the patient voice through submission of regulatory comments, participation in conferences, and active working groups.
Thank you to all our working group members, roundtable participants, and supporters, as you advance our mission to improve the efficiency and accessibility of lung cancer clinical research. Continue reading to find out more about our third quarter updates:
LUNGevity Hosts Multi-Stakeholder Regulatory Series, Part 1
LUNGevity’s Annual Regulatory Series Part 1 drew over 55 participants to Washington, DC on September 18—including drug sponsors, U.S. FDA representatives, academic clinicians, and patient advocates—to discuss pressing challenges in clinical trial design and execution. Discussions centered around leveraging patient experience data for decision-making, pre- and post-market, as well as celebrating ten years of TCTI and the impact of our efforts to improve clinical trial efficiency and accessibility.
LUNGevity Participates in Conferences Looking to the Future of Drug and Diagnostic Development
Brittany McKelvey, Vice President of Regulatory Policy, presented original research from TCTI on the use and interpretation of duration of response as an endpoint in lung cancer drug development at the American Association for Cancer Research (AACR) Drug Discovery and Development Meeting in July. She also participated in a panel at the meeting, Navigating the Current Regulatory Trends Shaping the Future of Cancer Drug Development. Lastly, Tod Guidry, Associate Director of Regulatory and Diagnostics Policy, attended the 18th Annual Next Generation Dx Summit which featured discussion on recent advances and implementation considerations for early cancer detection tests.
LUNGevity Submits Comments to FDA and EMA
LUNGevity continues to advocate for patients’ interests through public responses to regulatory guidance. We provided comments on draft guidance to the US Food and Drug Administration (FDA) on Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products, wherein we voiced support for improved efficiency and a reduction in unnecessary animal use provided the rigorous standards for demonstration of safety and efficacy of therapies for patients are maintained. Our comments to FDA on the draft guidance on Demonstrating Substantial Evidence of Effectiveness advocated for trial designs conducive to a robust assessment of both safety and effectiveness of new treatments, while appropriately balanced with flexibilities to facilitate broad participation and minimize patient burden.
We also shared comments with the European Medicines Agency (EMA) in response to their reflection paper on the Investigation and Assessment of Cardiovascular Safety of Anticancer Medicinal Products. We expressed support for a risk-based approach for patient eligibility criteria selection as well as cardiovascular assessments to avoid overly burdening or restricting patients in their trial participation.
LUNGevity Discusses Progression-Free Survival 2 (PFS2) in Oncology Clinical Trials: Project SignifiCanT
Project SignifiCanT (Statistics in Cancer Trials), established by the FDA Oncology Center of Excellence, promotes collaboration and engagement among diverse stakeholders in designing and analyzing cancer clinical trials. LUNGevity jointly organized a forum on September 22 on “Progression-Free Survival 2 (PFS2) in Oncologic Drug Development.” This discussion among multi-disciplinary experts considered the objectives, trial designs, and methodological and interpretation challenges when incorporating PFS2 in cancer clinical trials for regulatory decision-making.
LUNGevity Publishes Recommendations in Clinical Lung Cancer
The result of a LUNGevity multi-stakeholder working group comprised of industry and clinical experts, Streamlining the Frequency, Conduct, and Location of Assessments in Registrational Lung Cancer Clinical Trials for Supplemental Applications: Recommendations of a LUNGevity Foundation Multistakeholder Working Group was published in Clinical Lung Cancer. These recommendations for streamlining lung cancer clinical trial assessments support reduced patient and site burden for clinical trial participation for more representative patient populations.
LUNGevity Comments Supporting Bolstering US Clinical Trial Participation
LUNGevity continues to be the patient voice in conversations centered on clinical trial reform and ensuring the US is a global leader in oncology drug development. This quarter, we submitted comments to the Request for Information (RFI) from the HHS Office of Inspector General Regarding the Federal Anti-Kickback Statute and Beneficiary Inducements CMP, highlighting the importance of financial support for clinical trial participation, particularly for out-of-pocket non-medical costs. We also responded to the RFI on Commonsense Policy Options to Lower Drug Prices for Patients from the Senate Finance Committee Minority Staff and Senator Wyden, focusing on bolstering biopharmaceutical innovation in the US.
If you would like to learn more about these and other ongoing TCTI initiatives at LUNGevity and get involved, please email [email protected].
If you are not on our mailing list and wish to be, please email [email protected].